Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial
Zi-Xian Wang, Chengxu Cui, Jun Yao, Yanqiao Zhang, Mengxia Li, Jifeng Feng, Shujun Yang, Yun Fan, Jianhua Shi, Xizhi Zhang, Lin Shen, Yongqian Shu, Cailian Wang, Tianyang Dai, Teng Mao, Long Chen, Zengqing Guo, Bo Liu, Hongming Pan, Shundong Cang, Yi Jiang, Junye Wang, Min Ye, Zhendong Chen, Da Jiang, Qin Lin, Wei Ren, Junsheng Wang, Lin Wu, Yong Xu, Zhanhui Miao, Meili Sun, Conghua Xie, Ying Liu, Qifeng Wang, Lina Zhao, Qi Li, Canhong Huang, Ke Jiang, Kunyu Yang, Daojun Li, Yunpeng Liu, Zhitu Zhu, Rixin Chen, Liqun Jia, Wei Li, Wangjun Liao, Hong-Xu Liu, Daiyuan Ma, Jie Ma, Yanru Qin, Zhihong Shi, Qichun Wei, Ke Xiao, Yan Zhang, Ying Zhang, Xin Chen, Guanghai Dai, Jianxing He, Junhe Li, Guanghui Li, Yong Liu, Zhihua Liu, Xianglin Yuan, Junping Zhang, Zhichao Fu, Yifu He, Fang Ju, Zheng Liu, Peng Tang, Tiejun Wang, Weibo Wang, Jing Zhang, Xianming Luo, Xiongwen Tang, Rena May, Hui Feng, Sheng Yao, Patricia Keegan, Rui-Hua Xu, Feng Wang, Zi-Xian Wang, Chengxu Cui, Jun Yao, Yanqiao Zhang, Mengxia Li, Jifeng Feng, Shujun Yang, Yun Fan, Jianhua Shi, Xizhi Zhang, Lin Shen, Yongqian Shu, Cailian Wang, Tianyang Dai, Teng Mao, Long Chen, Zengqing Guo, Bo Liu, Hongming Pan, Shundong Cang, Yi Jiang, Junye Wang, Min Ye, Zhendong Chen, Da Jiang, Qin Lin, Wei Ren, Junsheng Wang, Lin Wu, Yong Xu, Zhanhui Miao, Meili Sun, Conghua Xie, Ying Liu, Qifeng Wang, Lina Zhao, Qi Li, Canhong Huang, Ke Jiang, Kunyu Yang, Daojun Li, Yunpeng Liu, Zhitu Zhu, Rixin Chen, Liqun Jia, Wei Li, Wangjun Liao, Hong-Xu Liu, Daiyuan Ma, Jie Ma, Yanru Qin, Zhihong Shi, Qichun Wei, Ke Xiao, Yan Zhang, Ying Zhang, Xin Chen, Guanghai Dai, Jianxing He, Junhe Li, Guanghui Li, Yong Liu, Zhihua Liu, Xianglin Yuan, Junping Zhang, Zhichao Fu, Yifu He, Fang Ju, Zheng Liu, Peng Tang, Tiejun Wang, Weibo Wang, Jing Zhang, Xianming Luo, Xiongwen Tang, Rena May, Hui Feng, Sheng Yao, Patricia Keegan, Rui-Hua Xu, Feng Wang
Abstract
Platinum-based chemotherapy is the standard first-line treatment for advanced esophageal squamous cell carcinoma (ESCC). In this phase 3 study (ClinicalTrial.gov: NCT03829969), 514 patients with treatment-naïve advanced ESCC were randomized (1:1) to receive toripalimab or placebo in combination with paclitaxel plus cisplatin (TP) every 3 weeks for up to 6 cycles, followed by toripalimab or placebo maintenance. At the prespecified final analysis of progression-free survival (PFS), a significant improvement in PFS is observed for the toripalimab arm over the placebo arm (hazard ratio [HR] = 0.58; 95% CI, 0.46-0.74; p < 0.0001). The prespecified interim analysis of overall survival (OS) also reveals a significant OS improvement for patients treated with toripalimab plus TP over placebo plus TP (HR = 0.58; 95% CI, 0.43-0.78; p = 0.0004). The incidences of grade ≥3 treatment-emergent adverse events are similar between the two arms. Toripalimab plus TP significantly improves PFS and OS in patients with treatment-naïve, advanced ESCC, with a manageable safety profile.
Keywords: PD-1 inhibitor; advanced esophageal squamous cell carcinoma; double-blind; immunotherapy; multi-center; paclitaxel plus cisplatin; randomized study.
Conflict of interest statement
Declaration of interests X.L. is employed by Shanghai Junshi Biosciences. X.T., H.F., and S. Yao are employed by Shanghai Junshi Biosciences and TopAlliance Biosciences. R.M. and P.K. are employed by TopAlliance Biosciences. R.-H.X. has served as a consulting or advisory role for Bristol-Myers Squibb, Merck Serono, Roche, Astellas, and AstraZeneca. All other authors have no competing interests.
Copyright © 2022 Elsevier Inc. All rights reserved.
Source: PubMed